TheraRadar
Data updated: May 26, 2026

CAVERJECT IMPULSE (alprostadil)

Prostaglandin Receptor Agonists Trial Activity: Stable 1 active trials
Urology Approved 2002-06-11

Caverject Impulse is a medication used to help patients with erectile dysfunction. It is also used as a diagnostic tool alongside other tests to help healthcare providers evaluate erectile issues. This prostaglandin E1 agonist provides a direct option for managing these conditions and assisting with medical assessments.

Source: FDA Label • Pfizer • Prostaglandin Analog
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CAVERJECT IMPULSE Works

This medication works by relaxing smooth muscle and dilating the arteries within the penis. This process expands internal spaces and traps blood by compressing the veins, a sequence known as the corporal veno-occlusive mechanism that produces an erection.

Source: FDA Label

Development Insights

Biopeutics Co., Ltd conducting 1 trials (20%)
9 indications explored (Moderate)
→ end stage cardiac failure (1 trials)
→ hfref - heart failure with reduced ejection fraction (1 trials)
→ nyhf class iii-iv (1 trials)
1
Indication
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-06-11
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer
Active Ingredient: ALPROSTADIL

CAVERJECT IMPULSE Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 2002 to 2022
Dec 2022 SUPPL
Label · Labeling
FDA Letter Label
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)
Oct 2016 SUPPL
Label · Labeling
FDA Letter Label

What CAVERJECT IMPULSE Treats

1 indications

CAVERJECT IMPULSE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Erectile Dysfunction
Source: FDA Label

CAVERJECT IMPULSE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

7

Same indication, different mechanism — what else might this patient receive?

VYBRIQUE
IBSA
2025 1 indic.
AVANAFIL
HETERO LABS
2024 1 indic.
Unlock 5 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CAVERJECT IMPULSE

3 of 8

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AVANAFIL
AVANAFIL
1 shared
HETERO LABS LTD V
Shared indications:
Erectile Dysfunction
CIALIS
TADALAFIL
1 shared
Eli Lilly
Shared indications:
Erectile Dysfunction
EDEX
ALPROSTADIL
1 shared
ENDO OPERATIONS
Shared indications:
Erectile Dysfunction
View all 8 similar drugs Pro
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT00610051 3-T02-07-0106 Ph 3 not yet recruiting ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure
NCT02895373 ECMO_PGE1 ECMO_PGE1_2.1 Ph 2 terminated PGE1 as Additive Anticoagulant in ECMO-Therapy
NCT03296670 LSG1501104 Ph 4 completed Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP
NCT02228850 NexMed 2014-RPS-001 Ph 2 completed Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
NCT01776320 103243 Ph 4 withdrawn Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CAVERJECT IMPULSE FDA Label Details

Indications & Usage

FDA Label (PDF)

CAVERJECT IMPULSE is indicated for the treatment of Erectile Dysfunction.

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Data Sources

FDA Approval: NDA021212 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment